US20060245627A1 - Noninvasive dynamic analysis system and method of use thereof - Google Patents

Noninvasive dynamic analysis system and method of use thereof Download PDF

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Publication number
US20060245627A1
US20060245627A1 US10/545,498 US54549805A US2006245627A1 US 20060245627 A1 US20060245627 A1 US 20060245627A1 US 54549805 A US54549805 A US 54549805A US 2006245627 A1 US2006245627 A1 US 2006245627A1
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joint
analysis system
positions
sites
orientations
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Kouki Nagamune
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/45—For evaluating or diagnosing the musculoskeletal system or teeth
    • A61B5/4528—Joints
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1121—Determining geometric values, e.g. centre of rotation or angular range of movement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/45—For evaluating or diagnosing the musculoskeletal system or teeth
    • A61B5/4538—Evaluating a particular part of the muscoloskeletal system or a particular medical condition
    • A61B5/4585—Evaluating the knee
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes

Definitions

  • the present invention relates to an analysis system for noninvasively calculating the six degrees-of-freedom of the knee, or the like, of the human body, in real-time, and during a manual test.
  • the measurement is carried out using, for example, the Anterior Drawer test capable of being evaluated by a KT-1000 (TM), an X-ray or fluoroscopy.
  • the KT-1000 In the KT-1000 described above, only an anterior translation can be measured. Therefore, another translation, such as a thrust translation, and a rotational degree, such as a flexion degree, cannot be measured. Further, the KT-1000 is not suitable for the manual test such as the Lachman test and the Pivot Shift test, because, in the KT-1000, a relatively large mechanical orthosis is attached to the cruris.
  • each deviation of the six degrees-of-freedom (6 DOF) of the knee joint is measured for the assessment, by means of an X-ray photograph of the knee joint, before and after stressing the knee joint.
  • 6 DOF degrees-of-freedom
  • the dynamic measurement can be done by using fluoroscopy, however, a major measured object of the measurement is limited to the knee joint between the thigh and the cruris each having an implant inserted thereinto. Further, the measurement has a problem that the equipment for the measurement is large and a patient may be affected by X-rays. Therefore, the measurement cannot be easily carried out on an outpatient.
  • a clinical examiner usually evaluates the test only subjectively. Thus, it is a problem that the evaluation may vary between different examiners or even for one examiner. Further, it is difficult to quantitatively evaluate the motion of the knee joint during a dynamic manual test.
  • the equipment uses optical markers
  • the measurement cannot be carried out when the markers are positioned in an invisible area due to the positions and the motions of hands and legs of the examiner during the manual test.
  • the space required for the measurement is large.
  • pins for fixing the marker must be directly driven into the femur and the tibia. Therefore, it is not practical to apply the measurement using the optical markers to the clinical assessment of an outpatient.
  • an object of the present invention is to provide a noninvasive dynamic analysis system capable of feeding back a measured and analyzed result of a manual test to an examiner in real-time and of evaluating the result dynamically and quantitatively.
  • the invention provides a noninvasive dynamic analysis system for measuring and analyzing the motion of the joint of the human body, the analysis system comprising: an electromagnetic sensor for noninvasively measuring the positions and the orientations of two sites of the human body opposite each other in relation to the joint and during the motion of the joint; an electromagnetic measuring device for determining the positions and the orientations of the two sites based on information from the electromagnetic sensor; a processing device for calculating the degrees-of-freedom of the joint, based on the positions and the orientations of the two sites determined by the electromagnetic measuring device and the position of an anatomic reference point around the joint.
  • the electromagnetic sensor includes a transmitter for transmitting an electromagnetic wave and two receivers noninvasively fixed to the two sites on the human body and capable of receiving the electromagnetic wave transmitted by the transmitter.
  • the noninvasive dynamic analysis system may further comprise a display unit for indicating the result calculated by the processing device in real-time.
  • the joint measured by the noninvasive dynamic analysis system is preferably the knee joint.
  • the two sites are the thigh and the cruris and the processing device calculates the six degrees-of-freedom of the knee joint.
  • the noninvasive dynamic analysis system may further comprise a stylus having a sensor.
  • the position of the anatomic reference point may be inputted to the processing device by contacting the stylus to the anatomic reference point.
  • a method for noninvasively measuring and analyzing the motion of the joint of the human body comprising steps of: providing an electromagnetic sensor for noninvasively measuring the positions and the orientations of two sites of the human body opposite each other in relation to the joint, during the motion of the joint; determining the positions and the orientations of the two sites based on information from the electromagnetic sensor; determining the position of an anatomic reference point around the joint; and calculating the degrees-of-freedom of the joint, based on the positions and the orientations of the two sites and the positions of the anatomic reference point.
  • the electromagnetic sensor includes a transmitter for transmitting electromagnetic wave and two receivers capable of receiving the electromagnetic wave transmitted by the transmitter.
  • the step of providing the electromagnetic sensor may comprise noninvasively fixing the two receivers to the two sites of the human body.
  • the step of determining the position of the anatomic reference point may comprise calculating the position of the reference point by analyzing the positions and the orientations of the two receivers attached to the joint, obtained by a predetermined motion of the joint.
  • the step of calculating the degrees-of-freedom may comprise measuring at least one of a translation, a translation velocity and a translation acceleration of at least one degree-of-freedom of the joint.
  • the information of the positions and the orientations of the thigh and the cruris is obtained by the electromagnetic sensor. Therefore, the measurement can be carried out in the space required for a manual test. Further, the measurement is possible even when the sensor is covered by the hand of the examiner or the examiner is positioned between the sensors. In other words, there is no factor which may be an obstacle for the manual test, whereby the measurement in a normal manual test may be possible.
  • the sensor may be noninvasively and quickly fixed. Also, the sensor may be easily fixed by an inexperienced person, as it is not necessary to drive a pin into the human body, as in case of the optical sensor.
  • the quick and noninvasive measurement contributes to the reduction of pain or discomfort of the patient, thereby the measurement may be employed for a clinical outpatient.
  • FIG. 1 is a block diagram showing a general configuration of a noninvasive dynamic analysis system according to the invention
  • FIG. 2 is a general configuration according to a preferred embodiment of the noninvasive dynamic analysis system of FIG. 1 ;
  • FIG. 3 is a diagram showing an electromagnetic sensor attached to the thigh and the cruris of a patient by braces;
  • FIG. 4 is a diagram showing inputting a reference point by using a stylus
  • FIG. 5 is a diagram showing the positions of reference points around the knee joint
  • FIG. 6 is a diagram showing the construction of a coordinate system around the knee
  • FIG. 7 is a diagram showing one example for calculating 6 DOF of the knee joint
  • FIG. 8 is a graph showing time variation of a translation of the cruris relative to the thigh during the Pivot Shift test, measured by the noninvasive dynamic analysis system of the invention.
  • FIG. 9 is a graph showing time variations of a velocity and an acceleration of the translation of the cruris relative to the thigh during the Pivot Shift test, measured by the noninvasive dynamic analysis system of the invention.
  • a noninvasive dynamic analysis system herein is used as a generic term of a medical analysis system for calculating and analyzing parameters as a quantitative evaluation of the joint during a manual test, in which sensors are positioned at two sites, of the human body opposite to each other in relation to the joint, such as the thigh and the cruris.
  • FIG. 1 is a block diagram showing a general configuration of a noninvasive dynamic analysis system 10 according to the invention, adapted for the knee joint of the human body.
  • FIG. 2 is a general configuration of a preferred embodiment of the noninvasive dynamic analysis system.
  • the noninvasive dynamic analysis system 10 includes a transmitter 12 for transmitting electromagnetic wave or an electromagnetic signal; a first receiver 14 a and a second receiver 14 b fixed to the thigh and the cruris of the human body and capable of receiving the electromagnetic wave transmitted by the transmitter 12 ; an electromagnetic measuring device 16 for determining the positions and the orientations of the receivers 14 a and 14 b based on electric signals from the receivers; and a processing device 18 , such as a personal computer, for calculating six degrees-of-freedom of the knee joint based on information from the electromagnetic measuring device 16 regarding the positions and the orientations of the receivers.
  • a transmitter 12 for transmitting electromagnetic wave or an electromagnetic signal
  • a first receiver 14 a and a second receiver 14 b fixed to the thigh and
  • the personal computer 18 includes a display or a display unit 20 for indicating a calculated result in real-time.
  • the transmitter 12 and the two receivers 14 a and 14 b cooperate to constitute the electromagnetic sensor.
  • the processing device 18 may indicate the motion of the knee joint, as well as an analyzed result of the knee joint described below. Therefore, a problem with, or the incorrect positioning of, the electromagnetic sensor may be immediately found.
  • FIG. 3 is a front view of the right leg of the patient and shows preferred positions of the patient where the two receivers 14 a and 14 b are attached.
  • the receivers 14 a and 14 b may be fixed to the thigh 50 and the cruris 60 of the human body, respectively, by using braces 22 a and 22 b .
  • each of the receivers may be attached to any position of the thigh 50 or the cruris 60 , it is preferable that each receiver is attached to a site where the position and the orientation of each receiver are not substantially or little changed relative to the femur or the tibia, so as to improve a calculation accuracy of 6 DOF of the knee joint described below. Concretely, as shown in FIG.
  • the first receiver 14 a is attached to an outside portion of the thigh 50 , which is upwardly away from an upper part 51 of the patella by four times of the width of the finger.
  • the second receiver 14 b is attached to an inside portion of the cruris 60 , which is downwardly away from an lower part 61 of the tibial tuberosity by three times of the width of the finger.
  • each receiver is preferably attached to a site of the thigh 50 or the cruris 60 having relatively less muscle.
  • the receivers 14 a and 14 b are noninvasively fixed to the thigh and the cruris by the braces 22 a and 22 b , without being fixed directly to the femur and the tibia by pins or the like. This is a significant advantage.
  • a stylus 24 of a bar shape having a rear end 26 and a front end 28 .
  • a receiver 14 c which is preferably similar to the above receiver 14 a or 14 b , is mounted to the rear end 26 of the stylus 24 .
  • the coordinates of the reference points may be inputted.
  • any coordinate directed by the examiner may be inputted as one of the reference points.
  • the leg of the patient may be passively moved such that the leg moves in a predetermined motion, so as to construct a coordinate system by analyzing the information of the positions and orientations of the receivers 14 a and 14 b obtained by the predetermined motion.
  • the above anatomic reference points may be substituted by the tibial tuberosity, an inner edge and an outer edge of the patella, etc.
  • seven points are inputted as the above anatomic reference points.
  • three points or the greater trochanter 52 , the medial epicondyle 54 and the lateral epicondyle 56 are inputted as the reference points of the thigh 50 .
  • four points or the caput of fibula 62 , the intersection point 64 of the medial collateral ligament (MCL) and a joint line, the medial malleolus 66 and the lateral malleolus 68 are inputted as the reference points of the cruris 60 .
  • the joint line used herein is a line along a groove extending between the femur condyle and the tibia condyle.
  • a middle point of the medial epicondyle 54 and the lateral epicondyle 56 is defined as the origin O F of the thigh coordinate system.
  • a straight line extending through the greater trochanter 52 and the origin O F is defined as an axis X F .
  • a straight line extending through two points in a plane, including the origin O F and perpendicular to the axis X F is defined as an axis Y F , where the two points in the plane are intersection points of the plane and perpendicular lines extending from the medial epicondyle 54 and the lateral epicondyle 56 .
  • An axis Z F is a straight line perpendicular to both of the axes X F and Y F .
  • the thigh coordinate system is constructed by these three axes X F , Y F and Z F .
  • a middle point of the caput of fibula 62 and the intersection point 64 of the MCL and the joint line is defined as the origin O T of the cruris coordinate system.
  • a straight line extending through a middle point 67 of the medial malleolus 66 and the lateral malleolus 68 and the origin O T is defined as an axis X T .
  • a straight line extending through two points in a plane, including the origin O T and perpendicular to the axis X T is defined as an axis Y T , where the two points in the plane are intersection points of the plane and perpendicular lines extending from the intersection point 64 and the caput of fibula 62 .
  • An axis Z T is a straight line perpendicular to both of the axes X T and Y T .
  • the cruris coordinate system is constructed by these three axes X T , Y T and Z T .
  • 6 DOF of the knee joint i.e., a flexion degree, an abduction degree, a rotation degree, a translation of anterior direction, a translation of thrust direction and a translation of distraction direction
  • a flexion degree i.e., a flexion degree, an abduction degree, a rotation degree, a translation of anterior direction, a translation of thrust direction and a translation of distraction direction
  • 6 DOF of the knee joint i.e., a flexion degree, an abduction degree, a rotation degree, a translation of anterior direction, a translation of thrust direction and a translation of distraction direction
  • the flexion degree of 6 DOF may be calculated based on the relation between the floating-axis FA and the axis Z F ;
  • the abduction degree may be calculated based on the relation between the axes X F and Y T ;
  • the rotation degree may be calculated based on the relation between the floating-axis FA and the axis Z T ;
  • the translation of anterior direction may be calculated based on the relation between an intersection point P 1 , of the floating-axis FA and the axis X F , and an intersection point P 2 , of the floating-axis FA and the axis Y T ;
  • the translation of thrust direction may be calculated based on the relation between the intersection point P 1 , and the origin O F ;
  • the translation of distraction direction may be calculated based on the relation between the intersection point P 2 and the origin O T .
  • One of conventional methods for clinically determining 6 DOF described above is a manual measuring method, in which an X-ray photograph is at first taken and, then, a protractor or a ruler is applied to the photograph. Alternatively, the protractor or the ruler is directory applied to the thigh and the cruris. Disadvantages of the method are that a measurement error may be large as the measurement is manually carried out and that the measurement cannot be dynamically carried out as the measurement in the method is possible only at one time or at one position. Contrarily, it is advantageous to use the analysis system of the invention, by which the dynamic measurement is possible and the result of the measurement may be indicated in real-time.
  • the Anterior Drawer test should be performed when the flexion degree is equal to 30, 60 or 90 degrees, the flexion degree is roughly and subjectively determined by the examiner. The flexion degree, which is therefore conventionally inaccurate in the test, may be accurately adjusted by the analysis system of the invention.
  • the display of the personal computer of the analysis system may indicate three-dimensional images of the thigh and the cruris of the patient, as well as 6 DOF of the knee joint in real-time.
  • FIG. 8 is a graph indicating a change of the translation of the anterior direction of 6 DOF relative to time, in the Pivot Shift test for evaluating the stability of rotation, which was measured by using the noninvasive dynamic analysis system.
  • a dashed line of the FIG. 8 is a graph indicating the flexion degree of the knee joint.
  • transfer of data from each receiver to the processing device was accelerated by using binary data.
  • a sampling period of the data from each receiver was 60 Hz.
  • FIG. 9 is a graph indicating changes of the velocity and the acceleration of the anterior translation relative to time, which were measured at the same time as the change of FIG. 8 .
  • a point A of FIG. 8 indicates that the change of the anterior translation had a local minimum value when the examiner performed the Pivot Shift test (i.e., the examiner displaced the cruris relative to the thigh while applying a force to the knee joint).
  • the motion of the joint near the local minimum point A is very important.
  • the motion or the condition of the joint can be determined only by a palpation of the examiner, therefore, the accuracy of the examination may have a large error, depending on the skill of the examiner.
  • the motion of the joint may be quantitatively measured in real-time and the accuracy of the examination may be greatly improved, in relation to the knee joint having, for example, an insufficiency of the anterior cruciate ligament (ACL).
  • ACL anterior cruciate ligament
  • a point A of FIG. 9 corresponds to the point A of FIG. 8 .
  • Any of the above translation, velocity and acceleration is available for the analysis of the motion of the joint at the point A.
  • the acceleration is the best for examining the condition of the joint. This is because the acceleration is less affected by a motion speed of the joint or a way of applying a force to the joint by the examiner.
  • the noninvasive dynamic analysis system of the invention 6 DOF of the knee joint of the patient may be noninvasively and dynamically measured. Therefore, the analysis system may be clinically used for an outpatient, thereby the examination in a clinical manual test may be evaluated more objectively. As the measured data may be stored and recalled at any time, the change between before and after an operation or the recovery after the operation may be checked. Further, by using the electromagnetic sensor, many advantages may be obtained as follows:
  • the manual test using the system of the invention may be carried out easier than the test using a mechanical measurement device in which the patient is restrained by a large mechanical orthosis.
  • the analysis system of the invention may be applied to the clinical manual test.
  • the analysis system of the invention is preferably applied to the assessment of a hinge type joint such as the knee joint and the elbow joint, the system may be obviously applied to another type of joint.

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EP1938749A2 (en) * 2006-12-27 2008-07-02 DePuy Products, Inc. Apparatus for monitoring the range of motion of a joint
EP2042110A1 (en) * 2007-09-30 2009-04-01 DePuy Products, Inc. Orthopaedic Surgical Instruments
WO2009156097A1 (de) * 2008-06-27 2009-12-30 Bort Medical Gmbh Vorrichtung zum bestimmen der stabilität eines kniegelenks
US20100234770A1 (en) * 2004-12-08 2010-09-16 Perception Raisonnement Action En Medecine Computer assisted orthopedic surgery system for ligament reconstruction
US8361076B2 (en) 2007-09-30 2013-01-29 Depuy Products, Inc. Patient-customizable device and system for performing an orthopaedic surgical procedure
US8641721B2 (en) 2011-06-30 2014-02-04 DePuy Synthes Products, LLC Customized patient-specific orthopaedic pin guides
US8979855B2 (en) 2007-09-30 2015-03-17 DePuy Synthes Products, Inc. Customized patient-specific bone cutting blocks
US9138239B2 (en) 2007-09-30 2015-09-22 DePuy Synthes Products, Inc. Customized patient-specific tibial cutting blocks
US9173662B2 (en) 2007-09-30 2015-11-03 DePuy Synthes Products, Inc. Customized patient-specific tibial cutting blocks
US9786022B2 (en) 2007-09-30 2017-10-10 DePuy Synthes Products, Inc. Customized patient-specific bone cutting blocks
WO2017216476A1 (fr) * 2016-06-16 2017-12-21 Sysnav Procédé d'estimation de l'orientation relative entre tibia et fémur
WO2018063920A1 (en) * 2016-09-27 2018-04-05 Arthrex, Inc. System and method for quantifying joint characteristics
CN107981867A (zh) * 2017-12-04 2018-05-04 成都思悟革科技有限公司 一种基于电磁场动作捕捉的膝盖康复辅助装置
US10149722B2 (en) 2010-02-25 2018-12-11 DePuy Synthes Products, Inc. Method of fabricating customized patient-specific bone cutting blocks
US10638970B2 (en) 2017-03-08 2020-05-05 Strive Orthopedics, Inc Method for identifying human joint characteristics
US11051829B2 (en) 2018-06-26 2021-07-06 DePuy Synthes Products, Inc. Customized patient-specific orthopaedic surgical instrument
US11771344B2 (en) 2020-10-27 2023-10-03 Medtronic Navigation, Inc. Sensor measurement for motor control

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JP5392671B2 (ja) * 2008-12-02 2014-01-22 学校法人早稲田大学 歩行計測装置
US8444564B2 (en) * 2009-02-02 2013-05-21 Jointvue, Llc Noninvasive diagnostic system
CN104083173B (zh) * 2014-07-04 2015-11-18 吉林大学 一种四足动物运动观测***
JP6108627B2 (ja) * 2014-09-26 2017-04-05 アニマ株式会社 膝関節回旋の解析装置
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US20100234770A1 (en) * 2004-12-08 2010-09-16 Perception Raisonnement Action En Medecine Computer assisted orthopedic surgery system for ligament reconstruction
US9248001B2 (en) * 2004-12-08 2016-02-02 Perception Raisonnement Action En Medecine Computer assisted orthopedic surgery system for ligament reconstruction
US20080161731A1 (en) * 2006-12-27 2008-07-03 Woods Sherrod A Apparatus, system, and method for monitoring the range of motion of a patient's joint
EP1938749A3 (en) * 2006-12-27 2008-12-17 DePuy Products, Inc. Apparatus for monitoring the range of motion of a joint
EP1938749A2 (en) * 2006-12-27 2008-07-02 DePuy Products, Inc. Apparatus for monitoring the range of motion of a joint
US9173662B2 (en) 2007-09-30 2015-11-03 DePuy Synthes Products, Inc. Customized patient-specific tibial cutting blocks
US10828046B2 (en) 2007-09-30 2020-11-10 DePuy Synthes Products, Inc. Apparatus and method for fabricating a customized patient-specific orthopaedic instrument
US8357111B2 (en) 2007-09-30 2013-01-22 Depuy Products, Inc. Method and system for designing patient-specific orthopaedic surgical instruments
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